Top 10 Tips for Improving Readability of Informed Consent Documents

1. PLAIN LANGUAGE: Use simple words for medical/scientific jargon- do not use the word and the definition in parentheses. Just use plain language.
    
2. SIMPLE WORDS: Use words with less than 3 syllables, e.g., use “about” instead of “approximately.” See word replacement websites below.
    
3. ACTIVE VOICE means the noun subject does the action verb: “We will measure your blood pressure,” not passive, e.g., “Your blood pressure will be measured by…”
    
4. ONE THOUGHT SENTENCES: Break sentences with multiple thoughts into one thought per sentence.
    
5. FONT: Use size 12, Sans serif fonts such as Arial, Calibri, Tahoma.
    
6. WHITE SPACE: use margins of minimum 1 inch; “squeezing” content to minimize consent length does not help readability.
    
7. FORMAT: use left justified, right ragged format – gives reader visual cues.
    
8. EMPHASIZE: use Italics, bold or all small caps to emphasize important points, but NOT all at once, in other words, DO NOT do this: THIS IS IMPORTANT.
    
9. REVIEWER: have a lay person read your document and ask them comprehension questions.
    
10. LISTS: use bulleted or numbered lists when 3 or more are items are included in text.

Word Replacement Websites

University of Michigan Library Plain Language Medical Dictionary

Multi-Regional Clinical Trials Glossary

National Comprehensive Cancer Network Informed Consent Language Database

Help with Sentence Structure

The CDC guide, "Everyday Words for Public Health Communication" shows how to use the plain language word substitute in a sentence. 

Readability Websites

The Flesch-Kincaid score shows the required education level needed to understand a written passage.  Informed consent documents have a target of no more than an 8th grade level.  There are many free websites to check reading levels, such as Automatic Readability Checker.  Another option is to use Microsoft Word spell check for readability: tap File-Options-Proofing and Check "Show readability statistics" to get the Flesch-Kincaid score.  The goal should be a score of 70 or greater:

60-69 = Standard

50-59 = Fairly Difficult

30-49 = Difficult

0-29 = Very Confusing

The HRP guidance, Building Your Consent Document provides sample language and tips to aid you in drafting your consent form.

9/30/2022